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INFLUENZA ANTIVIRALS, DIAGNOSTICS AND DEVICES


Antiviral Drugs

Antiviral medications lessen the impact of a virus after an individual has been infected, and are the principal mode of treatment for influenza infections. Under certain circumstances, these drugs can also reduce transmission of the virus or even prevent infection.

Two U.S.-licensed antiviral drugs are effective against the human and H5N1 influenza viruses. Tamiflu is manufactured by Roche as oral capsules or liquid suspension. Relenza®, manufactured by GlaxoSmithKline as a powder, is administered via a respiratory inhaler. Both belong to a class of drugs known as neuraminidase inhibitors, which work by blocking the ability of the virus to multiply beyond the infected host cell.

As part of the HHS Pandemic Influenza Plan, HHS must:

  • Establish national influenza antiviral drug stockpiles to treat 25% of the U.S. population during a pandemic, plus an immediate readiness cache of 6 million treatment courses for containment at pandemic onset;
  • Support the advanced development of new and promising influenza antiviral drugs toward U.S. licensure; and
  • Boost U.S.-based production of antiviral drugs.

Accomplishments

Antivirals

To fulfill antiviral drug stockpile goals, BARDA has:

  • Procured treatment courses for storage in the Strategic National Stockpile (SNS ) by the end of 2007 - completing the federal contribution to the antiviral goal; and
  • Supported States to purchase treatment courses of antivirals by the end of 2007 towards the treatment course goal for State stockpiles under a federal subsidy.
  • Together, the Federal and State stockpiles comprise the treatment courses needed to cover 25% of the U.S. population as well as provide the needed cache of courses for the early stages of a pandemic.

To support antiviral development and manufacturing ramp-up, BARDA:

  • Awarded contracts in 2007 and 2011 for the advanced development and domestic industrialization of new influenza neuraminidase inhibitor antiviral drugs;
  • Awarded a contract in 2012 for the advanced development of a new class of antiviral drugs.

Diagnostics

Quick and accurate diagnosis of pandemic influenza viruses in humans is essential to early treatment. Currently available tests require specially equipped laboratories, and take as long as one to two weeks to obtain results. BARDA awarded contracts to two consortiums for advancing innovative platform technologies applicable to influenza diagnostic testing in September 2010.

Work BARDA funded led to a recent FDA 510(k) clearance for the Focus Diagnostics Simplexa Flu A/B & RSV Direct Test on the 3M™ Integrated Cycler. The test also received a CLIA moderate complexity determination allowing it to be made available to a greater range of health care professionals than previous tests. The test can provide near-patient, quality, molecular testing at community hospitals and clinics and frees labs from costly, time-consuming extraction procedures. This makes it easier and faster for laboratories to perform sensitive testing for influenza virus and for respiratory syncytial virus (RSV). The tests can be done locally without delays from transporting specimens to distant labs.

Other Non-Pharmaceutical Countermeasures

BARDA has supported the development of a next-generation, easy to use portable ventilator. This ventilator, which is designed to be used with multiple populations, including vulnerable neonates, will offer a low-cost increase in medical surge capabilities.

Industry partners are encouraged to visit the BARDA Broad Agency Announcement and sign up for a BARDA TechWatch meeting.

Website Refresh

www.medicalcountermeasures.gov is pleased to announce a phased launch of our newly redesigned public website. We are making website improvements to provide a more modern and customer-centric web experience. Over the next several months you will see differences throughout the site while we continue implementing updates. Thank you for your understanding and please let us know if you have any questions: mailto:techwatchinbox@hhs.gov